Repetitive Transcranial Magnetic Stimulation for Schizophrenia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Must not be taking: CNS active drugs

Disqualifiers: Intellectual disability, Substance use, Neurologic disorders, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve cognitive skills in individuals with schizophrenia or schizoaffective disorder. It employs repetitive transcranial magnetic stimulation, a non-invasive procedure using magnetic fields to stimulate nerve cells, to target specific brain networks and assess changes in brain activity and behavior. The goal is to identify a safe and effective treatment for cognitive issues in these conditions, with potential future applications for other disorders like autism. Suitable participants have schizophrenia or schizoaffective disorder, are receiving stable psychiatric treatment, and have not experienced recent medication changes or hospitalizations. As an unphased trial, this study offers the chance to contribute to groundbreaking research that could lead to new treatments for cognitive issues.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but your medications will be reviewed by a doctor to decide if you can participate. Any recent changes in your medications or hospitalizations within the past 30 days may affect your eligibility.

What prior data suggests that this method is safe for individuals with schizophrenia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe and well-tolerated for people with schizophrenia. Studies indicate that individuals with schizophrenia are not more likely to experience side effects, such as seizures. Additionally, research has found that rTMS can safely help reduce certain symptoms of schizophrenia, like hearing voices. Overall, rTMS is considered a promising and noninvasive treatment option with a good safety record. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it targets the brain's Default Mode Network (DMN) with magnetic pulses, a novel approach for treating schizophrenia. Unlike traditional treatments like antipsychotic medications, which mainly focus on chemical imbalances, rTMS uses magnetic fields to modulate brain activity directly. This technique offers a non-invasive alternative with potentially fewer side effects and the possibility of quicker symptom relief. Researchers are excited as it could reshape how we approach brain disorders by directly influencing brain networks.

What evidence suggests that repetitive transcranial magnetic stimulation is effective for schizophrenia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can alleviate negative symptoms of schizophrenia, such as lack of motivation and difficulty in socializing. Studies have found that rTMS improves thinking skills, memory, and language abilities in these patients. In this trial, participants will receive a specific type of rTMS targeting the Default Mode Network, which has led to noticeable improvements compared to fake treatments, providing real benefits. Additionally, rTMS has safely reduced auditory hallucinations in some cases. Overall, these findings suggest rTMS could be a promising treatment for cognitive and memory issues in schizophrenia. ^{2 3 4 6 7}

Who Is on the Research Team?

Heather Ward, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with schizophrenia or schizoaffective disorder, aiming to improve their cognitive performance. It's also open to healthy participants for comparison. Specific eligibility details are not provided, but typically include age range, mental and physical health status.

Inclusion Criteria

Must be able to read, speak and understand English

I am between 18 and 65 years old.

I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

DSM-5 intellectual disability

Substance use disorder (other than nicotine) within the past three months

Current, active suicidal ideation with intent or plan, as assessed by a score of 5 or higher on the Brief Psychiatric Rating Scale question #4 Suicidality

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 5 sessions of active cTBS to the DMN in a single day with a 30-minute inter-session interval

1 day

Follow-up

Participants are monitored for changes in functional connectivity and cognitive performance

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Repetitive Transcranial Magnetic Stimulation

Trial Overview The study tests if accelerated inhibitory stimulation of the Default Mode Network (DMN) using cTBS can change network activity and improve cognition in people with schizophrenia/schizoaffective disorder and in healthy individuals.

How Is the Trial Designed?

Group I: Default Mode Network-Targeted cTBS Experimental Treatment 1 Intervention

All participants receive 5 sessions of active cTBS (600 pulses) to the DMN, with a 30-minute inter-session interval.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38232567/

An umbrella review of systematic reviews and meta-analyses Most reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165178124000155

Efficacy of repetitive transcranial magnetic stimulation ... Most reviews indicate that rTMS has an effect on negative symptoms, executive function, working memory, and language function in patients with schizophrenia.

3. psychiatrist.com psychiatrist.com/pcc/effectiveness-repetitive-transcranial-magnetic-stimulation-depression-schizophrenia-obsessive-compulsive-disorder-umbrella-meta-analysis/

Effectiveness of Repetitive Transcranial Magnetic ... rTMS was superior to sham in the reduction of negative symptoms of schizophrenia (mean difference [MD]: 0.47; 95% CI, 0.23–0.7; P < .0001).

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2825941

Repetitive Transcranial Magnetic Stimulation for Auditory ... The findings of this randomized clinical trial suggest that imaging-navigated rTMS may effectively and safely alleviate AVH in patients with schizophrenia.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01551979

Therapeutic Efficacy of Transcranial Magnetic Stimulation ... The primary outcome is improvement in negative symptoms related to schizophrenia. The investigators are focusing on negative symptoms given their greater ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11908856/

Safety of rTMS for Schizophrenia: A Systematic Review ... rTMS is safe and well tolerated for people with schizophrenia. Individuals with schizophrenia are not at increased risk for adverse effects, including seizure.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT00783120

Repetitive Transcranial Magnetic Stimulation (rTMS) for the ... Prefrontal repetitive transcranial magnetic stimulation (rTMS), a promising noninvasive biological technique, applied adjuvant to ongoing antipsychotic ...